Why choose personalizedx for Vysis ALK?
If your laboratory does not run molecular tests—such as the FISH-based (fluorescence in situ hybridization) Vysis ALK (Vysis ALK Break Apart FISH Probe Kit) to identify ALK gene rearrangements in patients with non-small cell lung cancer— PersonalizeDx can enable you to expand your service offerings. In this way, you can provide important information to oncologists that can aid in the selection of appropriate ALK-directed therapy.
As a companion diagnostic test, Vysis ALK has these primary benefits:
- The test accurately identifies ALK gene rearrangements in NSCLC patients.
- Early FISH testing at diagnosis can assist physicians in determining appropriate ALK-directed therapy.
- Vysis ALK is the only FDA-approved ALK companion diagnostic validated in XALKORI® (crizotinib) clinical trials.
The National Comprehensive Cancer Network (NCCN Guidelines™) recognizes the Vysis ALK Break Apart FISH Probe Kit (Vysis ALK) as a specifically designed method for diagnosing ALK-rearranged adenocarcinomas.1
XALKORI® clinical trial information, Phase 21
- 136 patients with locally advanced or metastatic ALK-positive NSCLC were treated with single-agent XALKORI® in a multi-center,
- ALK-positive NSCLC was identified using the Vysis ALK Break Apart FISH Probe Kit.
- Patients received 250 mg of XALKORI® orally twice daily.
- Primary endpoint: Objective Response Rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST).
- Median duration of treatment: 22 weeks.
- Results: 1 complete and 67 partial responses for an ORR of 50% (95% CI: 42%, 59%). 79% of objective tumor responses were achieved during the first 8 weeks of treatment.
Patients in this clinical trial were all ALK-positive and treated with XALKORI®, regardless of the phenotypic characteristics of sex, age, race, smoking status, or the histological classification of their NSCLC.
Demographic and Disease Characteristics
a Response was assessed by the investigator
b One patient was not evaluable for response
c Preliminary estimate using Kaplan-Meier method.
+ Censored values
CR = Complete Response
PR = Partial Response
In addition to Vysis ALK, PersonalizeDx offers a range of other lung cancer molecular tests.